BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2934584 · Received January 10, 2013

    Report

    Report Number
    1720753-2013-00477
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE CPU AND BACKPLANE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE FSE REPORTED THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16125 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1